Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy

NCT00593853 | Terminated Phase 2 DMC

• 2 other identifiers: LEUPR_L_0107-0350-C
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer with an LHRH-agonist.

Conditions

Prostatic Neoplasms; Fatigue

Keywords

LHRH-agonist related fatigue

Outcome Measures

Primary Outcomes (1)

• To assess the ability of methylphenidate 5 mg BID (10 mg daily) to reduce LHRH-agonist-related fatigue in prostate cancer patients as measured by the Functional Assessment of Cancer Therapy Fatigue subscale (FACT-F).

  3 months pre-treatment (LHRH-agnost naive group only), randomization, 6 weeks, 10 weeks, 12 weeks, 24 weeks

Secondary Outcomes (3)

• Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Bruera Global Fatigue Severity Scale

  Screening Visit 1, 3 months pre-treatment (LHRH-agonist naive group only), Screening Visit 2 (LHRH-agonist naive group only), Randomization, 2 weeks, 6 weeks, 10 weeks, 12 weeks, 24 weeks

• Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Centre for Epidemiological Studies Depression Scale(CESD)

  Screening Visit 1, 3 months pre-treatment (LHRH-agonist naive group only), Screening Visit 2 (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks

• Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Medical Outcomes Study 36-Item Short Form (SF-36)

  3 months pre-treatment (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Methylphenidate Hydrochloride

2

PLACEBO COMPARATOR

Drug: Matched Placebo

Interventions

Methylphenidate Hydrochloride DRUG

Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.

Also known as: Ritalin

1

Matched Placebo DRUG

Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.

Also known as: Inert Filler (lactose)

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and ≤ 85 years
• Histologically confirmed prostate cancer
• Currently receiving LHRH-agonist therapy for greater than 6 months with measurable fatigue, defined as a score of \>1 on the Bruera global fatigue severity scale OR
• Deemed eligible to commence LHRH-agonist therapy, with confirmation of fatigue at Screening Visit 2
• Have a serum PSA which is stable or decreasing based on the PSA trend over the last 2 values taken at least 2 months apart, with the more recent value taken at least 2 months after initiation of LHRH-agonist therapy.
• Have adequate liver and renal function (Bilirubin ≤ 1.5 x ULN and AST, ALT and Serum Creatinine \< 2 x ULN)
• Able to swallow and retain oral medication
• Life expectancy of at least 1 year
• Able to read and write in English (and therefore accurately complete the required study questionnaires), understand instructions related to study procedures and give written informed consent.

You may not qualify if:

• Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (other exceptions are superficial bladder cancer or non-melanoma skin cancer)
• Previous chemotherapy within the last 5 years
• Anemia (Hemoglobin \< 100 g/L)
• Myocardial infarction within past 6 months
• Any unstable serious co-existing medical condition(s) including but not limited to ; unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, Severe bleeding diseases or immune disorders
• Severe depression as defined by CES-D score \>27
• History of motor tics, seizures or a family history of Tourette's syndrome
• Infection with HIV (Human Immunodeficiency Virus), HBV (Hepatitis B) or HCV (Hepatitis C)
• Evidence of drug or alcohol abuse
• Known hypersensitivity to methylphenidate
• Possess any other contraindications to methylphenidate use

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sanofi: collaborator

Study Sites (1)

UHN Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Richard PO, Fleshner NE, Bhatt JR, Hersey KM, Chahin R, Alibhai SM. Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy. BJU Int. 2015 Nov;116(5):744-52. doi: 10.1111/bju.12755. Epub 2015 Jun 8.

  PMID: 24684534 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Fatigue

Interventions

Methylphenidate; Lactose

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Neil E Fleshner, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Shabbir MH Alibhai, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, FRCSC

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

CA (1)